Ottawa, ON — September 26, 2003 — The following life sciences news briefs were recently published by Industry Canada:
1) Pharmaceuticals Update
Lorus announces trial with GTI-2040 with US National Cancer Institute
Lorus Therapeutics (Toronto) announced that approval has been obtained from Health Canada for initiation of a clinical trial of GTI-2040 in combination with docetaxel for the treatment of advanced non-small cell lung cancer (NSCLC), as part of a Phase II clinical program of GTI-2040 in collaboration with the US National Cancer Institute (NCI). The study will be conducted under the direction of Dr Natasha Leighl at Princess Margaret Hospital in Toronto, a leading clinical and research centre for cancer. Additional leading oncology centres and investigators participating in this study include the Ottawa Regional Cancer Centre (Dr Scott Laurie), Hamilton Regional Cancer Centre (Dr Peter Ellis), and London Regional Cancer Centre (Dr Mark Vincent). The study is supported by the Cancer Therapy Evaluation Program (CTEP), an NCI agency that is providing both program coordination and financial sponsorship as part of its mission to support the development of novel anticancer agents.
Stressgen Presents Results of Trial at ICAAC
Stressgen Biotechnologies (Victoria) presented interim data from its Phase II trial with HspE7 in recurrent respiratory papillomatosis (RRP), a seriously debilitating and sometimes life-threatening condition for children, at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago, Illinois. These data will be available on the company’s website at www.stressgen.com. The primary endpoint of the Phase II trial evaluated the interval between surgeries following treatment with HspE7 compared to the pretreatment surgical interval. The increase in the first post-treatment intersurgical interval is statistically significant (p less than 0.01); likewise, the increase in the median of all post-treatment intervals is statistically significant (p less than 0.05). For the overall population, the first post-treatment interval increased 78.6% over the pretreatment interval, resulting in fewer surgeries for these patients. Almost half of these children were rated “severe” by a laryngeal scale score or by having papillomas in their lungs (lung involvement is the most serious manifestation of RRP).
OncoGenex and Isis expand antisense drug development collaboration
OncoGenex Technologies (Vancouver), and Isis Pharmaceuticals, (Carlsbad) announced they have expanded their antisense drug development partnership to include the development of the second-generation antisense anti-cancer drug candidate, OGX- 225. The compound is the first bi-specific antisense inhibitor, a single-stranded antisense drug designed to inhibit the production of two proteins simultaneously, to enter into preclinical development. OGX-225 targets both insulin-like growth factor binding protein-5 (IGFBP-5) and insulin-like growth factor binding protein-2 (IGFBP-2), two molecules involved in the development of metastatic disease in hormone-regulated tumors such as prostate and breast cancers. Specific financial terms of the deal were not disclosed.
Nymox announces up to four new investigational drugs
Nymox Pharmaceutical (Dorval) announced that the company’s management anticipates filing up to 4 Investigational New Drug applications (INDs) for new products in the next 12 months. The company plans to provide further information as the necessary milestones are achieved prior to filing with regulatory authorities. Nymox received FDA clearance for its NicAlert test in October, 2002. The company’s IND for NX-1207, its prostate drug, was accepted by the FDA and the new drug is currently in US clinical trials. The company recently announced positive interim Phase I safety data for NX-1207. In addition, Nymox’s CLIA certified clinical reference laboratory markets the company’s patented AlzheimAlert urine test in the US
2) Diagnostics and Therapeutics Update
Generex announces publication of three scientific papers
Generex Biotechnology (Toronto), announced the publication of three papers by scientists at Wayne State University and Antigen Express, Generex’s immunomedicine subsidiary. The papers highlight the development progress of a novel genetic cancer vaccine that suppresses the expression of the Ii protein in tumors. In addition, the company is expanding its R&D collaboration with Wayne State toward studies that will enable clinical trial initiation of the novel vaccine. The approach includes injection of tumors with proprietary molecules that trigger a potent anti-tumor immune response. Importantly, a tumor-specific T- helper cell response is elicited. The papers were published recently in peer-reviewed journals: 1. Lu X, et al, “Tumor immunotherapy by converting tumor cells to MHC class II-positive, Ii protein-negative phenotype,” Cancer Immunology Immunotherapy June 19, 2003 (electronic publication). 2. GG Hillman, et al, “Generating MHC Class II+/Ii- Phenotype After Adenoviral Delivery of both an Expressible Gene for MHC Class II Inducer and an Antisense Ii-RNA Construct”, Gene Therapy 10: 1512- 1518, (August 2003). 3. GG Hillman, et al., “Radiation Improves Intratumoral Gene Therapy for Induction of Cancer Vaccine in Murine Prostate Carcinoma”, Human Gene Therapy 14:763-775 (May 20, 2003)
CEO biotechnology survey reveals hot button issues
Egon Zehnder International, a global leader in executive search, released the results of its survey of CEOs and senior executives in Canada’s biotechnology healthcare sector. The survey revealed several hot button issues which continue to be an ongoing concern for CEOs: raising capital, recruiting and retaining talent, appropriately compensating executives, securing regulatory approval and establishing effective corporate governance. The immediate concern of Canadian biotechnology healthcare CEOs is raising capital. Nearly 30% of those interviewed highlighted this as their most significant obstacle for success in 2003. The second most important challenge cited was the acquisition and retention of top talent, especially in scientific areas (R&D, clinical trials, and medical affairs) and in business development.
Scientists turn to biotechnology for biowarfare antidotes
Some Canadian and US researchers say they’ve found the key to creating antidotes for biological weapons. Plasma from genetically modified cows produces a human antibody that could protect people from dangerous viruses. Dr James Robl of Hematech in Sioux Falls, South Dakota says the antibodies could protect against botulism toxins, anthrax and smallpox. Hematech’s defence project is paid for mostly by US military money, as is the work of a Montreal lab. For researchers at Nexia Biotechnologies (Montreal) the goal is protection from a chemical threat. “It probably takes about 100 milligrams or 200 milligrams of this material to protect you against a wide range of nerve agents,” said Jeffrey Turner of Nexia as he held up a vial of powder. The research started in genetically modified goats. Their milk contains a human protein called ProtexiaTM, which protects us from natural toxins in food. In its modified, purified form, the hope is ProtexiaTM would protect us from much stronger chemical onslaughts like the terrorist attack in a Tokyo subway in 1995. Sarin gas killed 12 people and harmed thousands. “Right now, a clinician would end up treating the symptoms using drugs which are 25 to 60 years old,” said Dr Kent Harding of Defence R&D Canada in Ottawa. Harding said the drugs work but there is room for improvement through biotechnology.
3) Medical Devices
Health Canada approves enhancements to World Heart’s Novacor LVAS
World Heart (Ottawa) announced that Health Canada has approved its submission to incorporate enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients’ quality of life by having a quieter
device and smaller, lighter, longer-lasting battery packs. These enhancements, which are commercially available in Europe and under review for approval in the US by the Food and Drug Administration (FDA), are the result of the evolution of extensive clinical experience with the Novacor LVAS. Improvements that will directly benefit recipients include: Quieter pump operation, new battery packs that are 40% lighter and operate for 60% longer, a smaller, quieter battery charger.
ART announces start of clinical trial with Ottawa regional
ART Advanced Research Technologies (Montreal), a leading developer of bio-optical imaging technologies and the Ottawa Regional Women’s Breast Health Centre at the Civic Campus of the Ottawa Hospital, are pleased to announce the start of a multi-centre clinical trial for ART’s SoftScan optical breast imaging device, of which the Ottawa Regional Women’s Breast Health Centre is one of the approved clinical sites. Imaging of up to 200 study volunteers at Ottawa Regional Women’s Breast Health Centre is expected to be concluded within the next 12 months. ART has received authorisations – from both Health Canada and the Ottawa Health Research Institute Ethics Board – to begin this clinical trial entitled Optical Characterization of Breast Tissue. Dr Nathalie Duchesne, radiologist and Head of Breast Imaging and Intervention at the Ottawa Regional Women’s Breast Health Centre, will be acting as principal investigator of this first clinical collaboration between the Ottawa Regional Women’s Breast Health Centre and ART. The objective of this study is to acquire biological data on a broad range of breast tissue, including targeted breast lesions. This data will be used in the final development of the SoftScan image processing system and will help to characterize the signatures of malignant and benign breast lesions for diagnostic purposes.
Angiotech, Boston Scientific announce positive results
Angiotech Pharmaceuticals (Vancouver), the original developer of the paclitaxel-coated stent technology, was notified by its corporate partner, Boston Scientific, of the nine-month results from its Taxus IV clinical trial. The trial enrolled 1,326 patients at 73 sites in the US, assessing the safety and efficacy of a slow-release formulation paclitaxel-eluting stent. Boston made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, DC. The randomized, double-blind pivotal trial is designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions 10 – 28 mm in length and 2.5 – 3.75 mm in diameter. The study is using Boston Scientific’s Taxus Express coronary stent system. This system is built on the Express coronary stent system, which offers excellent deliverability to the treatment site and superb conformability to the vessel wall.
Nymox reports new positive studies of AlzheimAlert product
Nymox Pharmaceutical (Dorval) announced that new studies of its AlzheimAlert test product have demonstrated that the product performs extremely well over time. This new data indicates that unlike many other well-known test technologies, the AlzheimAlert test does not vary unreliably over time in the same individual. According to Nymox scientists, this increases the utility of the AlzheimAlert test in the tracking of individuals progress and their responses to drug treatments. The study compared the results of multiple AlzheimAlert urine tests repeated on the same patient over different time periods from three months to three years apart. The samples tested came from patients with Alzheimer’s disease and from normal control subjects. The study involved 25 individuals. All the multiple tests from the same individual gave the same clinical result: the positive tests all remained positive; the negative tests all remained negative. In no case did a patient testing positive initially later test negative.
Tm Bioscience to supply leading reference lab with genetic tests
Tm Bioscience (Toronto) announced that Mayo Foundation in Rochester, Minnesota has signed a two-year purchase agreement for the company’s Tag-It P450-2D6 drug metabolism test. This test will be used by Mayo Medical Laboratories, which provides lab testing and interpretive services for Mayo and for medical centres and hospitals around the world. The Tag-It P450-2D6 test was commercially launched by Tm Bioscience in June 2003. Through Tm Bioscience’s Early Access Program, Mayo has already started their internal validation process for the test.
Spectral announces clearance to market the EAA in the European Union
Spectral Diagnostics (Toronto) announced receipt of notification and registration of a CE marking of conformity for its Endotoxin Activity Assay (EAA), as an aid in risk assessment of patients in the ICU for developing severe sepsis. The completion of a CE marking of conformity, along with Spectral’s ISO 9001 and ISO 13485 certification allows the company to legally market the EAA in the European Union (EU) immediately, as well as after the full implementation of the In Vitro Diagnostics Directive (IVDD) in December 2003.
Medical Ventures launches SLEEVE II trials
Medical Ventures (Richmond) is pleased to announce that the first six Over and Under Pericardium Covered stents have been successfully implanted as part of the Sleeve II clinical trial intended to support European regulatory approval for the product. These first six stents were implanted at hospitals in Milan, Italy, by Dr Antonio Colombo, whom they say is one of the world’s foremost authorities in interventional cardiology. Medical Ventures is the exclusive manufacturer of the Over and Under Pericardium Covered stent for Design & Performance Canada, The Over and Under stent is intended for the interventional treatment of stenosed saphenous vein grafts, aneurysms, thrombus, artery perforations and other conditions that can be difficult or impossible to treat using a conventional non-covered stent. Conventional stents can allow material to pass between the stent struts and permit the flow of blood through the stent wall, which makes them unsuited for these types of procedures.
Medcomsoft experiences increased demand for its EMR products in the US
MedcomSoft (Toronto) announced that the company has experienced a significant increase in demand for its American product, MedcomSoft Record, that has resulted in a number of new software license sales in the US during the current fiscal quarter that has, to date, exceeded the total number of licenses sold in the entire prior fiscal year. Specific details of these sales will be reported in connection with the announcement of the company’s annual and quarterly financial results. Management attributes this sharp increase to several factors including a higher market demand for premium electronic medical records application software in the US, the restructuring of MedcomSoft distribution channel, the release (in spring 2003), of an enhanced version of MedcomSoft’s core application Record version 1.3 and a large increase of physician referrals by satisfied users.
CryoCath receives FDA approval to start atrial fibrillation study
CryoCath Technologies (Montreal) announced that is has received IDE (Investigational Device Exemption) conditional approval from the FDA to initiate a study to treat atrial fibrillation (AF). The study will involve a “tool box” approach to treat AF with up to three different CryoCath catheters: Arctic Circler Linear, Freezor Xtra and Freezor MAX. AF is the most prevalent cardiac arrhythmia, affecting four million patients in the western world, and is one of the leading causes of stroke and short-term hospitalizations with 400,000 new cases annually.
Medtronic and Medusa team up
Medtronic Physio-Control (Halifax) and Medusa Medical Technologies (Redman) announced that they have formed a strategic partnership to market and develop electronic patient data reporting systems for the EMS (emergency medical services) market th
at they say allows easier and more accurate patient data capture, transfer and analysis. The Siren ePCR Suite from Medusa is an electronic patient care reporting and data management system. It can be linked directly to LIFEPAK monitor/defibrillators from Medtronic Physio-Control for automatic capture and transfer of cardiac rhythm and vital signs. Both companies will adapt existing products to work more closely together and in the future will jointly develop new products for the EMS customer. The first products are expected to be available this year.
4) Genomics Update
Epilepsy Canada contributes to discovery of new gene
Epilepsy Canada announced that thanks to the support from donors across the country, a research grant has contributed to identifying a gene responsible for the most severe form of adolescent epilepsy, called Lafora disease. The discovery was published in the September edition of the scientific magazine Nature Genetics. The research team was conducted by Drs Berge Minassian and Stephen Scherer of Hospital for Sick Children (Toronto) and the University of Toronto.
McGill University and Genome Quebec Innovation Centre
Paul L’Archevque, President and CEO of Genome Quebec, announced that the McGill University and Genome Quebec Innovation Centre, established only 21 months ago and now located at 740 Docteur Penfield, has already generated economic spin-offs of over $4 million, together with over 200 high-quality genomic and proteomic research jobs. “We’re especially pleased with the results to date,” said Mr L’Archevque during the inauguration of the research centre. “Over 200 researchers have been working in either the McGill University and Genome Quebec Innovation Centre or at affiliated centres since its creation in January 2002, and the set of science and technology platforms provided by the centre have so far helped support over 120 large genomic and proteomic research projects at 35 institutions across Canada, the US and in many other countries.” Under the scientific leadership of Dr Thomas Hudson, the McGill University and Genome Quebec Innovation Centre is home to a number of mobilizing projects and provides Canadian and international researchers with a set of advanced technologies designed specifically for high-throughput research, coupled with a bioinformatics network and four platforms delivering genotyping, sequencing, DNA biochip and proteomics services.
Sick Kids identify gene for most severe form of adolescent epilepsy
An international research team led by Drs Berge Minassian and Stephen Scherer of the Hospital for Sick Children and the University of Toronto has identified a gene responsible for the most severe form of teenage-onset epilepsy, known as Lafora disease (LD). The discovery is reported in the September issue of the scientific journal Nature Genetics. “Epilepsy is one of the most common neurological disorders affecting over 40 million people worldwide,” said Dr Berge Minassian, one of the study’s senior authors, an HSC neurologist and scientist, and an assistant professor in the department of paediatrics at U of T. “Lafora disease is one form of epilepsy that occurs during early adolescence and is characterized by seizures and progressive neurological degeneration. Death usually occurs within a decade of the first symptoms.” Fifty years of investigation led doctors to suspect that Lafora disease was caused by problems with carbohydrate metabolism in the brain. Beyond this, however, the fundamental defect triggering the malfunction was unknown. In 1998, the HSC team identified the first gene implicated in Lafora disease, called EPM2A.
5) Industry Update
Spectral Diagnostics (Toronto), developer of diagnostic technologies, today announces it has accepted terms of a commercial operating line of credit for $1,250,000 with RBC Royal Bank’s Life Science & Healthcare Markets Team under Standard Commercial Banking Terms.
Oncolytics Biotech (Calgary) has formed a Scientific Advisory Board to provide scientific and clinical guidance on the development of Reolysin, the Company’s proprietary formulation of the human reovirus. The advisory board includes Ramon Alemany, PhD, Richard Gorlick, MD, Alan Tuchman, MD, and Frank Tufaro, PhD.
Labopharm (Laval) announced that it has completed the treatment stage for two pivotal Phase III clinical trials in the US for the company’s lead in-house product, a once-daily version of the analgesic tramadol. The company expects to report the results from the trials during the fourth quarter of 2003.
TSO3 (Quebec City) has appointed Ann Hewitt, a former Steris sales and marketing executive, as area sales director – US market. She will assume strategic marketing responsibilities in business development efforts for the launch of the 125L Ozone Sterilizer in US.
Generex Biotechnology (Toronto) announced that the National Cancer Institute has awarded a Small Business Innovative Research (SBIR) grant to support development of a novel vaccine for T- helper cell-stimulating peptide vaccines to treat malignant melanoma. The research will be carried out by Antigen Express, Generex’s subsidiary focused on the development of novel immunomedicines.
Pharmahorizons (Montreal) and CanReg (Hamilton) announce that they have entered into a Cooperative Services Agreement. Under the terms of the agreement, Pharmahorizons and CanReg will develop and launch professional development programs for regulatory affairs professionals in the life sciences field.
Medical Ventures (Richmond) announced that its cardiac surgery division, Performance Medical Devices, has received ISO 13485 registration for the sale of medical devices.
BCY LifeSciences (Toronto) announced that options to acquire up to a maximum of 320,000 common shares of BCY, at an exercise price of $0.185 per share, were granted on August 21, 2003 to certain directors and employees and BCY’s investors relations firm. The expiry date of such options is August 21, 2008.
Angiotech Pharmaceuticals, (Vancouver), announced that it has filed in all Canadian provinces a preliminary short form prospectus and related documents in connection with the offering in Canada, the US and internationally of 5,000,000 newly issued common shares, excluding an over-allotment option held by the underwriters to purchase up to an additional 750,000 common shares.
ART Advanced Research Technologies (Montreal) and GE Medical Systems, a unit of General Electric (New York) announce the first sale of the pre-clinical optical molecular imager, SAMI, to the National Institutes of Health (NIH) in the US. SAMI is exclusively distributed worldwide by GE Medical Systems.
Generex Biotechnology, (Toronto) a developer of buccal drug delivery, announced the commencement of a Phase II-B trial in Canad of Oralin, the company’s proprietary oral insulin spray formulation.
QLT (Vancouver) announced that the US Food and Drug Administration (FDA) has granted fast track review status to Visudyne therapy for both the occult with no classic and the minimally classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) patient populations.
Bioniche Life Sciences (Belleville) completed the second tranche of a royalty enhanced debenture financing first announced on May 26, 2003. Under the two tranches, a total of $13.5 million has been advanced to Bioniche from the Business Development Bank of Canada and two other major Canadian financial institutions.
QLT (Vancouver) announced a favorable vote by the Medicare Coverage Advisory Committee regarding questions relevant to the decision to be made by the US Centers for Medicare and Medicaid Services (CMS) on whether to expand the current reimbursement of Visudyne Therapy to include patients with the occult choroidal neovascularization (CNV) due to age-related macular degeneration, the leading cause of blindness in patients over 50.
Medical Ventures (Vancouver) announces that Angiometrx will exhibit the Metricath System technology at the Transcatheter Car
diovascular Therapeutics 2003 International Symposium in Washington, DC., September 15-19.
Inex Pharmaceuticals (Vancouver) announced that it has increased the size of its board of directors to nine with the appointments of two new directors and the retirement of one director. Joining the INEX board are Gary E Frashier, president and Principal of Management Associates, a San Antonio-based consulting firm that provides strategic services to emerging companies in the life sciences field, and James W Hudson, CA, former senior vice president, finance and chief financial officer of Kinetek Pharmaceuticals, a private Vancouver-based drug discovery company.
Magistral Biotech (Montreal) announces that, as anticipated, it has begun the expansion of its factory located in Blainville, which will enable it to double the space available for its manufacturing equipment and for the storage of its products. The work, already commenced, aims to ensure the putting into place of the elements required in order for Magistral to commence the manufacturing of its products at the end of 2003.
Viventia Biotech (Toronto) announced the completion of the previously disclosed private placement equity financing with a European wholly owned subsidiary of Teva Pharmaceutical Industries providing for approximately $2.8 million (CDN) in funding. Teva purchased 14,021,000 units issued by the company. Each unit comprises one common share of the company and one common share purchase warrant. Each warrant enables the holder to purchase one common share of the company at an exercise price of $0.20 (CDN) for a period of up to five years after the closing.
Life Sciences News Brief is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Telephone: (613) 952-7700; E-mail: email@example.com).